NCT01686984

Brief Summary

The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease. The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

September 13, 2012

Last Update Submit

May 13, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Carbon dioxide elimination in a ventilator assisted breath.

    30 minutes

Secondary Outcomes (1)

  • Blood CO2 concentration.

    30 minutes

Study Arms (1)

Altered breath

EXPERIMENTAL

The group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath.

Other: Altered breath

Interventions

Altered breath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No known primary lung disease

You may not qualify if:

  • Primary lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Brain, Heart and Lungs, Neurosurgical Clinic, Skane University Hospital, Lund

Lund, Skåne County, 22185, Sweden

Location

Related Publications (1)

  • Sturesson LW, Malmkvist G, Allvin S, Collryd M, Bodelsson M, Jonson B. An appropriate inspiratory flow pattern can enhance CO2 exchange, facilitating protective ventilation of healthy lungs. Br J Anaesth. 2016 Aug;117(2):243-9. doi: 10.1093/bja/aew194.

Study Officials

  • Mikael Bodelsson, Professor

    Division of Anesthesia, Skane University Hospital, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 18, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations